NDC 49288-0836

Treatment Set TS344558

Treatment Set Ts344558

Treatment Set TS344558 is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Cladosporium Cladosporioides; Aspergillus Fumigatus; Cochliobolus Sativus; Aureobasidium Pullulans Var. Pullutans; Fusarium Oxysporum; Penicillium Chrysogenum Var. Chrysogenum; Phoma Destructiva; Rhizopus Stolonifer; Fraxinus Americana Pollen; Quercus Alba Pollen.

• Product ID: 49288-0836_3d2e8502-9a04-4060-a553-26e1bf285501
• NDC: 49288-0836
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS344558
• Generic Name: Treatment Set Ts344558
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1986-10-31
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: CLADOSPORIUM CLADOSPORIOIDES; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN
• Active Ingredient Strength: 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
• Pharm Classes: Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0836-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0836-3)

• Marketing Start Date: 1986-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0836-3 [49288083603]

Treatment Set TS344558 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-10-31
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
CLADOSPORIUM CLADOSPORIOIDES	.00008 g/mL

OpenFDA Data

• SPL SET ID: a2a38721-f395-4aeb-927b-35c959ce586e
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • A17SE577FM
  • PR9U2YPF3Q
  • D1A2NG69CK
  • 57L1Z5378K
  • 6AU0ZD8T1O
  • 4ZWY20GTGO
  • Z4Y9ZSV4KK
  • K20Y81ACO3
  • 52B29REC7H
  • G684LX721Q
  • X88DF51T48
  • 5398RXP8KU
  • 3Y1PE1GCIG
  • FEE198DK4Q
  • 577VA5B4HP
  • 1564HD0N96
  • 3LN5B70U4W

Pharmacological Class

• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]